Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 89
This randomised, open study in an outpatient clinic compared the effectiveness of the willow bark extract Assalix and rofecoxib (Vioxx) in treatment of low back pain (LBP).
A total of 228 patients with exacerbations of chronic LBP were allocated to receive randomly a daily Assalix dose containing 240 mg salicin or 12.5 mg Vioxx. The doses were chosen from existing recommendations. All patients were free to use whatever additional conventional treatments were thought necessary.
Groups were well matched. After 4 weeks, the Arhus Index had improved by about 20%, its pain component by about 30% and the total pain index by about 35%. About 60% of both groups responded well to the treatment (as judged by an improvement of ≥ 30% in the total pain index relative to its baseline). The improvement was also reflected reasonably well in the physicians’ and patients’ judgements of the effectiveness of treatment. In a retrospective power calculation, 114 patients per group was found to give > 95% power (1-β) to detect a between-group difference of 0.5 standard deviations in any of the metric pain indices (one-sided Wilcoxon rank sum test, U = 0.05). Few patients of either group resorted to the additional conventional treatment options. The incidence of adverse events was similar in both groups. Treatment with rofecoxib was about 40% more expensive than with Assalix.
There was no significant difference between the effectiveness of the two treatments at the chosen doses. Treatment with Assalix was less expensive.
